Pig

Chicken (broiler, replacement pullet, layer/breeder)

Turkey (poult (grower) and breeder)

Rabbit

For the treatment and metaphylaxis, when the disease is present in the group, of swine dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin. The presence of the disease in the group must be established before the product is used.

For the treatment of colitis caused by Brachyspira pilosicoli.

For the treatment of ileitis caused by Lawsonia intracellularis.

For the treatment of enzootic pneumonia caused by Mycoplasma hyopneumoniae.

For the treatment and prevention of chronic respiratory disease (CRD) and air sacculitis caused by Mycoplasma gallisepticum and Mycoplasma synoviae.

For the treatment and prevention of infectious sinusitis and air sacculitis caused by Mycoplasma gallisepticum, Mycoplasma meleagridis and Mycoplasma synoviae.

For the treatment and prevention of epizootic rabbit enterocolitis (ERE) (see section Amount to be Administered for further information regarding indications).

Animals should not receive products containing ionophores (monensin, narasin or salinomycin) during or for at least seven days before or after treatment with tiamulin. Severe growth depression or death may result.

Refer to section 'Interactions' for information regarding interaction between tiamulin and ionophores

In case of reduced feed intake, the inclusion levels in feed may need to be increased to achieve target dosage. Acute cases and severely diseased animals with reduced feed intake should be treated with a product of suitable formulation such as an injectable or water solution.

i. Special precautions for use in animals

It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.

Refer to section 'Interactions' for information regarding interaction between tiamulin and ionophores.

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals.

When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to European Standard EN 143. Wash contaminated skin.

In case of accidental ingestion, seek medical advice immediately and show the package insert or label to the physician.

People with known hypersensitivity to tiamulin should administer the product with caution.

On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.

Can be used in pigs during pregnancy and lactation.

Can be used in laying and breeding chickens and turkeys.

Can be used in rabbits during pregnancy and lactation.

Tiamulin has been shown to interact with ionophores such as monensin, salinomycin and narasin and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive products containing monensin, salinomycin or narasin during or at least 7 days before or after treatment with tiamulin. Severe growth depression, ataxia, paralysis or death may result.

If signs of an interaction do occur, administration of contaminated feed should be stopped immediately. The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin.

Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.

The product can be incorporated into pelleted feed at temperatures of 65ºC and maximums of 80ºC.

For incorporation into dry feed at the registered mill:

A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.

Calculations to achieve the correct dose rate and achieve the correct inclusion rate should be based on: - Inclusion rate (ppm) = dose rate (mg/kg bwt) x bodyweight (kg) / daily feed intake (kg).

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of tiamulin hydrogen fumarate has to be adjusted accordingly.

Treatment of Swine Dysentery caused by B. hyodysenteriae, treatment of Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli

Dosage: 5 - 10 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 7 to 10 consecutive days. The dosage will normally be achieved by an inclusion level of 100 – 200 ppm tiamulin hydrogen fumarate in the finished feed provided that feed intake is unaffected.

Treatment of Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis
Dosage: 7.5 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 10 to 14 consecutive days. The dosage will normally be achieved by an inclusion level of 150 ppm tiamulin hydrogen fumarate in the finished feed providing that feed intake is unaffected.

Treatment of Enzootic Pneumonia caused by M. hyopneumoniae

Dosage: 5.0 – 10.0 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 7 to 10 consecutive days. The dosage will normally be achieved by an inclusion level of 100 -200 ppm tiamulin hydrogen fumarate in the finished feed provided that feed intake is unaffected.

Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.

Treatment and prevention of Chronic Respiratory Disease (CRD) caused by M. gallisepticum and air sacculitis and infectious synovitis caused by and M. synoviae.

Dosage – Treatment and prevention: 25 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for the period of 3 to 5 consecutive days. This is normally achieved by an inclusion level of 250 - 500 ppm tiamulin hydrogen fumarate in finished feed provided that feed intake is unaffected. Inclusion levels in the higher range will in most cases be needed to avoid underdosing. In fast growing birds, e.g. broiler chickens during the first 2-4 weeks of life, inclusion levels in the lower range may be sufficient.

Treatment and prevention of infectious sinusitis and air sacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis.

Dosage – Treatment and prevention: 40 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for the period of 3 to 5 consecutive days. This is normally achieved by an inclusion level of 250 – 500 ppm tiamulin hydrogen fumarate in finished feed provided that feed intake is unaffected. Inclusion levels in the higher range will in most cases be needed to avoid underdosing. In fast growing birds, e.g. poults during the first 2-4 weeks of life, inclusion levels in the lower range may be sufficient.

Preventive treatment with tiamulin should only be initiated after confirmed infection with M. gallisepticum, M. synoviae or M. meleagridis and then as an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease in flocks where infection in ovum is likely because the disease is known to exist in the parent generation. The prevention strategy should include efforts to eliminate the infection from the parent generation.

Treatment of Epizootic Rabbit Enterocolitis (ERE) and prevention of ERE in farms with clinical signs of ERE in the previous fattening cycle as part of a programme including measures aiming to eradicate or control the infection in the farm.

Dosage: 3 mg tiamulin hydrogen fumarate /kg bodyweight daily. The dosage will normally be achieved by an inclusion level of 40 ppm tiamulin hydrogen fumarate in the finished feed provided that feed intake is unaffected. Treatment should be administered until 2 – 3 days after clinical signs has resolved. Prevention should be administered during 3 – 4 weeks from the first week after weaning.

Pigs: Single oral doses of 100 mg/kg bodyweight in pigs caused hyperpnoea and abdominal discomfort. At 150 mg/kg no CNS effects were noted except for sedation. At 55 mg/kg given for 14 days a transient salivation and slight gastric irritation occurred. A minimum lethal dose has not been established in the pig.

Poultry: The LD5 for chickens is 1290 mg/kg and turkeys 840 mg/kg bodyweight.

The clinical signs of acute toxicity in chickens are – vocalization, clonic cramps and lateral recumbency. In turkeys signs of acute toxicity include clonic cramps, lateral or dorsal recumbency, salivation and ptosis.

If signs of intoxication do occur promptly remove the medicated feed, replace with fresh unmedicated feed and apply supportive, symptomatic therapy.

Meat and offal:

Treatment (at 5-10 mg/kg bwt): 6 days

Meat and offal: 1 day

Eggs: 0 days

Meat and offal: 4 days

Meat and offal: 0 days